Earlier this month sports apparel giant Nike sued StockX LLC, a Michigan-based sneaker and streetwear resale marketplace, for offering to its customers non-fungible tokens (NFTs) depicting Nike’s sneakers. The claims asserted in the February 3 complaint filed in federal court in the Southern District of New York include trademark infringement, trademark dilution and unfair competition, all stemming from inclusion of Nike’s trademarks (e.g. Nike, Air Jordan, Jumpman, the “Swoosh” Design) in the shoe images depicted in the NFTs provided by StockX.
This is not the first case of its kind. In January, Hermes sued a digital artist for unauthorized reproductions of its well-known Birkin bag in a line of NFTs released by the artist called “Metabirkins.” And before that, in November 2021, Miramax – the studio that produced the 1994 cult movie classic Pulp Fiction – filed suit to enjoin Quentin Tarantino from releasing NFTs based off of his original handwritten script of the movie, including scenes from an early script that were cut from the final version.
The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a total of six letters in 2021 — four Untitled Letters and two Warning Letters — to pharmaceutical or biologics companies for promotional materials that allegedly misbranded prescription drug or biologics products. The two Warning Letters issued in 2021 addressed prescription drug promotion. Two of the Untitled Letters also addressed prescription drug promotion, while the other two letters addressed biologic product promotion.
OPDP also sent six letters in 2020; however, the majority that year (four) were Warning Letters, with only two being Untitled Letters. Both Warning and Untitled letters are made public on FDA’s website. Warning Letters are issued for violations of regulatory significance that may lead to enforcement action if not promptly and adequately corrected, whereas Untitled Letters cite violations that do not rise to the threshold of regulatory significance warranting a Warning Letter. Untitled Letters serve as the initial notification that FDA has taken notice of a violation and allow the company to come into compliance without further FDA regulatory action. Historically, OPDP has relied more heavily on Untitled Letters. 2020 was an outlier year with four Warning Letters versus two Untitled Letters, but 2021 signified a return to normalcy, as the agency issued twice as many Untitled Letters as Warning Letters.
I don’t love surprises. Well, if you want to send me a surprise red velvet birthday cake, please feel free. Otherwise, I like being prepared – and infringement of intellectual property is one type of surprise that you can prepare yourself to handle. To assist in that effort, here’s a non-exhaustive list of questions you can ask yourself and your team members, to help determine next steps if you suspect infringement of your trademarks or copyrights. These questions may also come in handy if you find yourself on the receiving end of an allegation of infringement.